The demographics of patients suffering valvular disease are broad and the treatment modalities for each are complex. Historically, patients younger than 65 years of age have been prescribed mechanical heart valves, while older patients have been prescribed bioprosthetic heart valves that are comprised of biological tissue mounted on a plastic or metallic supporting structure. However, the role of the patient in choosing a particular valve type is changing. In this regard, younger patients that are active now frequently opt for bioprosthetic valves, since such patients are unwilling to deal with the lifestyle changes that are required by mechanical valves and the associated chronic anticoagulation therapy. These patients often prefer undergoing repeat surgeries to replace a worn-out bioprosthetic valve, rather than deal with the lifestyle changes required by mechanical valves.
In view of the need for replacement of bioprosthetic heart valves, a cardiovascular valve assembly has been developed comprising an exchangeable valve member, including a leaflet component, and a docking station (also referred to herein as a “base member”). The docking station is permanently installed, and the valve member is detachably mounted or engaged with the docking station to allow exchange of the valve member. Accordingly, this two-piece valve assembly enables a valve member having a worn-out leaflet component to be exchanged without requiring open-heart surgery and long periods on cardiopulmonary bypass.
The present invention is directed to an improved cardiovascular valve assembly and a tool set for facilitating the removal and installation of an exchangeable valve member.